Bioequivalence and Bioavailability Forum

Dear Esha!

❝ Can we administer glucose solution to prevent hypoglycemia in bioequivalence of Acarbose combination with metformin study?

You have to. Please search the forum in the future - you would have found this post. See also FDA's guidances on acarbose and metformin (IR tablets, ER tablets).

❝ We are going to estimate change in serum glucose concentration by PD end point for Acarbose. Will glucose administration affect the study result?

Likely. That's a very tricky situation, because the PD endpoint of arcabose will be influenced by the effect of metformin. To be honest, I have not the slightest idea how you could demonstrate BE based on PD of arcabose and PK of metformin simultaneously.